Self-declarations of environmental classification in www.fass.se

In 2005 environmental information was published for the first two groups of products in www.fass.se, to test a new model for classification, developed on an initiative from LIF (The Research-Based Pharmaceutical Industry in Sweden). The initiative was a response to an increasing public demand for environmental information on pharmaceuticals and an attempt to develop a model accepted by Swedish stakeholders, but also by the global pharmaceutical industry. In 2010, all groups of pharmaceuticals (ATC codes) on the Swedish market had been the subject of an environmental risk assessment. During the implementation of the environmental classification system IVL Swedish Environmental Research Institute (IVL) performed a project with the aim to identify and address the pitfalls of the system. This project was financed by LIF and the Foundation for IVL Swedish Environmental Research Institute (SIVL). IVL reviewed the pre-published data and took part in a discussion, led by LIF, with the pharmaceutical companies about how to implement the guideline for environmental risk assessment, developed by LIF (LIF Expert Group Environment) in cooperation with stakeholders and the international industry. The goal of this reviewing process was to establish a common praxis for the implementation of the guideline among the different companies and to feed back the experience from the self-declaration process to the system owners, LIF. The review of pre-published environmental risk assessments and system evaluation is an on-going task and the present report describes the experiences from the review process during the year 2013. With its iterative process, IVL gives feedback to LIF regarding the system as such, both from a scientific perspective as well as from a quality assurance perspective. Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten.Report on how the work to implement environmental information in www.fass.se will be achieved through a common practice

Self-declarations of environmental classification at Fass.se

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The review of pre-published environmental risk assessments and system evaluation is an on-going task and the present report describes the experiences from the review process during the year 2014. With its iterative process, IVL gives feedback to LIF regarding the system as such, both from a scientific perspective as well as from a quality assurance perspective. In 2015, 400 environmental risk assessments were sent in for review. Of these 41% received the comment no remarks and were recommended to be published. Another 41% received the assessment remark and were recommended to be corrected before publication and 19% needed to be corrected and sent in for another review before publication. The number of times a document is re-sent in for revision has decreased during the last three years. One of the reasons is the development and implementation of the assessment tool, which has improved the review process and clarified the comments sent to the companies. The statistical calculations of the environmental risk assessments in this report are based on documents that were published at Fass.se during 2015. The total number of unique substances was 391 and 19% of these were classified regarding environmental risk. 50% were exempted from classification and 31% were reviewed, but no classification could be made due to lack of data. The work of improving the review system is an on-going process. Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten.Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The review of pre-published environmental risk assessments and system evaluation is an on-going task and the present report describes the experiences from the review process during the year 2014. With its iterative process, IVL gives feedback to LIF regarding the system as such, both from a scientific perspective as well as from a quality assurance perspective. In 2015, 400 environmental risk assessments were sent in for review. Of these 41% received the comment no remarks and were recommended to be published. Another 41% received the assessment remark and were recommended to be corrected before publication and 19% needed to be corrected and sent in for another review before publication. The number of times a document is re-sent in for revision has decreased during the last three years. One of the reasons is the development and implementation of the assessment tool, which has improved the review process and clarified the comments sent to the companies. The statistical calculations of the environmental risk assessments in this report are based on documents that were published at Fass.se during 2015. The total number of unique substances was 391 and 19% of these were classified regarding environmental risk. 50% were exempted from classification and 31% were reviewed, but no classification could be made due to lack of data. The work of improving the review system is an on-going process.This report describes the experiences gained during the review process in year 2015 of the system of self-declarations of environmental classification at www.Fass.se, and has been prepared with the aim to achieve transparency by explaining the role and the experiences of the reviewer, which may be useful in future development of the system. The main target groups are LIF and its member companies, as well as users of the environmental classifications, e.g. county councils and researchers

10 år med miljöklassificering av läkemedel på Fass.se

Temat för mötet var att sammanfatta vad som hittills har gjorts och att diskutera hur framtiden ser ut för miljöklassificering av läkemedel. Dagen var indelad i fyra olika sessioner, som behandlade följande: bakgrunden och syftet med miljöklassificeringen av läkemedel på www.fass.se; användningen av miljöklassificering av läkemedel på Fass.se; begränsningar och möjligheter vid lagstiftning och reglering samt hur arbetet med miljöinformation för läkemededel kan förbättras och få en bredare användning.Temat för mötet var att sammanfatta vad som hittills har gjorts och att diskutera hur framtiden ser ut för miljöklassificering av läkemedel. Dagen var indelad i fyra olika sessioner, som behandlade följande: bakgrunden och syftet med miljöklassificeringen av läkemedel på www.fass.se; användningen av miljöklassificering av läkemedel på Fass.se; begränsningar och möjligheter vid lagstiftning och reglering samt hur arbetet med miljöinformation för läkemededel kan förbättras och få en bredare användning. This report is only available in Swedish.Miljöklassificeringen av läkemedel på Fass.se har firat 10 år, vilket uppmärksammats genom ett dialogmöte i Stockholm den 7:e november 2016. I denna rapport redovisas diskussionerna från dagen

10 år med miljöklassificering av läkemedel på Fass.se

Temat för mötet var att sammanfatta vad som hittills har gjorts och att diskutera hur framtiden ser ut för miljöklassificering av läkemedel. Dagen var indelad i fyra olika sessioner, som behandlade följande: bakgrunden och syftet med miljöklassificeringen av läkemedel på www.fass.se; användningen av miljöklassificering av läkemedel på Fass.se; begränsningar och möjligheter vid lagstiftning och reglering samt hur arbetet med miljöinformation för läkemededel kan förbättras och få en bredare användning.Temat för mötet var att sammanfatta vad som hittills har gjorts och att diskutera hur framtiden ser ut för miljöklassificering av läkemedel. Dagen var indelad i fyra olika sessioner, som behandlade följande: bakgrunden och syftet med miljöklassificeringen av läkemedel på www.fass.se; användningen av miljöklassificering av läkemedel på Fass.se; begränsningar och möjligheter vid lagstiftning och reglering samt hur arbetet med miljöinformation för läkemededel kan förbättras och få en bredare användning. This report is only available in Swedish.Miljöklassificeringen av läkemedel på Fass.se har firat 10 år, vilket uppmärksammats genom ett dialogmöte i Stockholm den 7:e november 2016. I denna rapport redovisas diskussionerna från dagen

Self-declarations of environmental classification at Fass.se - Experiences from the reviewing process during 2019

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information, which is published on the open web-based portal www.Fass.se. Prior to publication the environmental risk assessments are reviewed by IVL Swedish Environmental Research Institute (IVL) as an independent, external part. The present report describes the experiences from the review process during the year 2019. In 2019, environmental risk assessments (ERAs) were sent in for review 421 times. 63% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 37% were recommended to be corrected or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2019 was 315. Of these substances 43% were exempted from classification, 27% were classified regarding environmental risk, and 30% could not gain any classification due to lack of data. The work of improving the review system is an on-going process. As a part of this work IVL performs studies and activities to increase the knowledge of pharmaceuticals in the environment. In 2018/2019 a model was developed for environmental assessment of pharmaceutical products, in regard to environmental risks related to emissions of Active Pharmaceutical Ingredient (API) from production processes and product carbon footprint in a life cycle perspective.Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten

Self-declarations of environmental classification at Fass.se

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information, which is published on the open web-based portal www.Fass.se". Prior to publication the environmental risk assessments are reviewed by IVL Swedish Environmental Research Institute (IVL) as an independent, external part. The present report describes the experiences from the review process during the year 2018. In 2018, 373 environmental risk assessments (ERAs) were sent in for review. Almost 60% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 40% were recommended or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2018 was 361. Of these substances a little more than half of them were exempted from classification, one fourth were classified regarding environmental risk, and the rest quarter could not gain any classification due to lack of data. The work of improving the review system is an on-going process. As a part of this work IVL performs studies and activities to increase the knowledge of pharmaceuticals in the environment. In 2018/2019 a model was developed for environmental assessment of pharmaceutical products, in regard to environmental risks related to emissions of Active Pharmaceutical Ingredient (API) from production processes and product carbon footprint in a life cycle perspective.Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten

Self-declarations of environmental classification at Fass.se

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The present report describes the experiences from the review process during the year 2016. Data for the statistical analyses are gained both from the Fass.se database and from the “progression list”, a spreadsheet the audit team uses to keep track of documents that have been reviewed or are under current review. In 2016, 450 environmental risk assessments were sent in for review. Of these 48% received the comment no remarks and were recommended to be published. 27% received the assessment remark and were recommended to be corrected before publication and 26% needed to be corrected and sent in for another review before publication. The total number of unique substances that were published at Fass.se during 2016 was 371. Of these 26% were classified regarding environmental risk, 34% were exempted from classification and 40% were reviewed, but no classification could be made due to lack of data. Of the classified substances 82% received the assessment insignificant risk. No substance was classified as posing high risk or being hazardous. Two substances (Estradiol and Terbinafine), published during 2016, were classified as posing a moderate risk. 60% of the unique substances were assessed for bioaccumulation potential but 90% of these were classified with low potential for bioaccumulation. 31% of the unique substances were assessed for degradation and 73% of these were classified as potentially persistent. The work of improving the review system is an on-going process. As a part of this work IVL Swedish Environmental Research Institute performs studies and activities to increase the knowledge of pharmaceuticals in the environment. During 2016 IVL organized a Dialogue meeting, “10 years of environmental classification of pharmaceuticals at Fass.se”, with representatives from administrative authorities, industry, stakeholders and scientists in order to present and discuss the work with environmental classification of pharmaceuticals (Graae et al. 2017). In addition, experiences from the reviewing process of the self-declaration system of environmental classification of pharmaceuticals at Fass.se were summarized and evaluated in a peer-reviewed article (Magnér et al. 2017).Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The present report describes the experiences from the review process during the year 2016. Data for the statistical analyses are gained both from the Fass.se database and from the “progression list”, a spreadsheet the audit team uses to keep track of documents that have been reviewed or are under current review. In 2016, 450 environmental risk assessments were sent in for review. Of these 48% received the comment no remarks and were recommended to be published. 27% received the assessment remark and were recommended to be corrected before publication and 26% needed to be corrected and sent in for another review before publication. The total number of unique substances that were published at Fass.se during 2016 was 371. Of these 26% were classified regarding environmental risk, 34% were exempted from classification and 40% were reviewed, but no classification could be made due to lack of data. Of the classified substances 82% received the assessment insignificant risk. No substance was classified as posing high risk or being hazardous. Two substances (Estradiol and Terbinafine), published during 2016, were classified as posing a moderate risk. 60% of the unique substances were assessed for bioaccumulation potential but 90% of these were classified with low potential for bioaccumulation. 31% of the unique substances were assessed for degradation and 73% of these were classified as potentially persistent. The work of improving the review system is an on-going process. As a part of this work IVL Swedish Environmental Research Institute performs studies and activities to increase the knowledge of pharmaceuticals in the environment. During 2016 IVL organized a Dialogue meeting, “10 years of environmental classification of pharmaceuticals at Fass.se”, with representatives from administrative authorities, industry, stakeholders and scientists in order to present and discuss the work with environmental classification of pharmaceuticals (Graae et al. 2017). In addition, experiences from the reviewing process of the self-declaration system of environmental classification of pharmaceuticals at Fass.se were summarized and evaluated in a peer-reviewed article (Magnér et al. 2017).IVL has since 2005, with the launch of the system of self-declarations of environmental classification at www.Fass.se, conducted a project focused on review of the self-declarations financed by LIF .This report describes the experiences gained during the review process in year 2016 and has been prepared with the aim to achieve transparency by explaining the role and the experiences of the reviewer, which may be useful in future development of the system. Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten

Self-declarations of environmental classification at Fass.se

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The present report describes the experiences from the review process during the year 2016. Data for the statistical analyses are gained both from the Fass.se database and from the “progression list”, a spreadsheet the audit team uses to keep track of documents that have been reviewed or are under current review. In 2016, 450 environmental risk assessments were sent in for review. Of these 48% received the comment no remarks and were recommended to be published. 27% received the assessment remark and were recommended to be corrected before publication and 26% needed to be corrected and sent in for another review before publication. The total number of unique substances that were published at Fass.se during 2016 was 371. Of these 26% were classified regarding environmental risk, 34% were exempted from classification and 40% were reviewed, but no classification could be made due to lack of data. Of the classified substances 82% received the assessment insignificant risk. No substance was classified as posing high risk or being hazardous. Two substances (Estradiol and Terbinafine), published during 2016, were classified as posing a moderate risk. 60% of the unique substances were assessed for bioaccumulation potential but 90% of these were classified with low potential for bioaccumulation. 31% of the unique substances were assessed for degradation and 73% of these were classified as potentially persistent. The work of improving the review system is an on-going process. As a part of this work IVL Swedish Environmental Research Institute performs studies and activities to increase the knowledge of pharmaceuticals in the environment. During 2016 IVL organized a Dialogue meeting, “10 years of environmental classification of pharmaceuticals at Fass.se”, with representatives from administrative authorities, industry, stakeholders and scientists in order to present and discuss the work with environmental classification of pharmaceuticals (Graae et al. 2017). In addition, experiences from the reviewing process of the self-declaration system of environmental classification of pharmaceuticals at Fass.se were summarized and evaluated in a peer-reviewed article (Magnér et al. 2017).Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The present report describes the experiences from the review process during the year 2016. Data for the statistical analyses are gained both from the Fass.se database and from the “progression list”, a spreadsheet the audit team uses to keep track of documents that have been reviewed or are under current review. In 2016, 450 environmental risk assessments were sent in for review. Of these 48% received the comment no remarks and were recommended to be published. 27% received the assessment remark and were recommended to be corrected before publication and 26% needed to be corrected and sent in for another review before publication. The total number of unique substances that were published at Fass.se during 2016 was 371. Of these 26% were classified regarding environmental risk, 34% were exempted from classification and 40% were reviewed, but no classification could be made due to lack of data. Of the classified substances 82% received the assessment insignificant risk. No substance was classified as posing high risk or being hazardous. Two substances (Estradiol and Terbinafine), published during 2016, were classified as posing a moderate risk. 60% of the unique substances were assessed for bioaccumulation potential but 90% of these were classified with low potential for bioaccumulation. 31% of the unique substances were assessed for degradation and 73% of these were classified as potentially persistent. The work of improving the review system is an on-going process. As a part of this work IVL Swedish Environmental Research Institute performs studies and activities to increase the knowledge of pharmaceuticals in the environment. During 2016 IVL organized a Dialogue meeting, “10 years of environmental classification of pharmaceuticals at Fass.se”, with representatives from administrative authorities, industry, stakeholders and scientists in order to present and discuss the work with environmental classification of pharmaceuticals (Graae et al. 2017). In addition, experiences from the reviewing process of the self-declaration system of environmental classification of pharmaceuticals at Fass.se were summarized and evaluated in a peer-reviewed article (Magnér et al. 2017).IVL has since 2005, with the launch of the system of self-declarations of environmental classification at www.Fass.se, conducted a project focused on review of the self-declarations financed by LIF .This report describes the experiences gained during the review process in year 2016 and has been prepared with the aim to achieve transparency by explaining the role and the experiences of the reviewer, which may be useful in future development of the system. Den här rapporten finns endast på engelska. Svensk sammanfattning finns i rapporten

Utveckling av analysmetoder inklusive detektionsgränser

Läkemedel är viktiga för hälsa och ökat välbefinnande i vårt dagliga liv. Läkemedel ger många fördelar såsom förbättrad livskvalitet, och efterfrågan kommer sannolikt att öka i framtiden på grund av en växande åldrande befolkning, kroniska livsstilssjukdomar, expanderande tillväxtmarknader samt framsteg inom den medicinska forskningen. Tyvärr innebär en ökad användning av läkemedel även en ökad belastning på miljön. Konsumtionen av mediciner bland befolkningen utgör den största spridningen av läkemedelsrester till miljön. Läkemedel som inte bryts ner helt i kroppen utsöndras, antingen som metaboliter eller i oförändrad form, via urin och avföring och hamnar i våra reningsverk. I reningsverken kan läkemedelsresterna antingen brytas ner, fastläggas i slammet eller hamna i sjöar, vattendrag och i kustvatten via det renade utgående avloppsvattnet. Utvärderingen av reningseffektiviteten av olika reningstekniker baseras vanligtvis på analyser av koncentration av läkemedelsrester. Det finns dock svårigheter med analysmetoderna då läkemedel utgör en heterogen grupp av ämnen, med stor variation i fysikaliska och kemiska egenskaper. Variationen kräver användandet av generella metoder för provberedning och analys. Påverkan från komplexa matriser, så som avloppsvatten, riskerar att försämra återvinningen av läkemedel vid provupparbetningen samt påverka signalen vid analys på instrument. Till exempel kan den höga halten av andra föreningar i inkommande avloppsvattnet störa analysen så att vissa läkemedel observeras vid lägre koncentrationer i det orenade vattnet än i det mer rena utgående avloppsvattnet. En annan orsak till att halter av läkemedel uppmäts som lägre i inkommande än utgående avloppsvatten kan vara att vissa läkemedel som metaboliseras i människokroppen återfår sin ursprungliga struktur i reningsverksprocessen och därmed uppmäts i större utsträckning i utgående avloppsvatten. Matriseffekter försämrar även detektionsgränserna av östrogena hormoner så att det med dagens analysmetoder är svårt att bestämma deras förekomst i avloppsvatten. Vissa antibiotika interagerar med fria joner från matrisen och bildar kelatkomplex, vilket ger försämrad återvinning och detektion. Då behovet är stort att kunna bedöma reningseffektivitet i avloppsreningsverk och koncentration av ämnen i avloppsvatten som kan påverka miljön har fokus för studien varit att utveckla och utvärdera förbättrade metoder för kvantitativ bestämning av läkemedelsrester i avloppsvatten. Användandet av en generell metod för provberedning och analys av läkemedel i komplexa matriser, så som avloppsvatten, gör det svårt att skilja läkedelssubstanserna från övrigt organiskt material i matrisen. Generella analysmetoder kan dock användas för att få en översiktlig bild av förekommande ämnen och halter i avloppsvatten samt för jämförelser av reningseffektivitet mellan olika reningstekniker eller olika reningsverk. I arbeten där utvärdering av reningseffektiviteten i ett avloppsreningsverk av enskilda ämnen eller halten av enskilda ämnen i utgående avloppsvatten är avgörande, kan t.ex. märkta internstandarder för respektive ämne eller metoder anpassade till enskilda ämnens kemiska fysikaliska egenskaper användas vid analys för att minimera matriseffekter. Resultaten visade att jon-suppression, dvs. nedtryckning av signalen vid analys på grund av konkurrens med koeluerande organiskt material i matrisen, var den viktigaste orsaken till den observerade ökningen i koncentration av läkemedelsrester från inkommande till utgående avloppsvatten. Resultaten visar en genomsnittlig jon-suppression på 56 % för de studerade läkemedlen i inkommande och 33 % i utgående avloppsvatten. Förluster i återvinning orsakat av konkurrens med annat organiskt material i matrisen vid provberedning alternativt omvandling av metaboliter av läkemedelsrester i avloppsvatten var av underordnad betydelse för flertalet ämnen. Risperidon och Fluoxetine visade stor påverkan av behandling avseende omvandlingsprodukter inklusive metaboliter. Utvecklingen av känsligare metod för kvantifiering av östrogena hormoner i utgående avloppsvatten resulterade i haltbestämningar under ng/L, med en kvantifieringsgräns (LOQ; S/N=10) för17-β-östradiol på 0,6 ng/L, östrone på 0,4 ng/L och 17-α-etinylöstradiol på 0,4 ng/L. Studien visade även att en tillsats av EDTA-Na2 till vattenprov innan upparbetning ökade återvinningen av merparten av de studerade antibiotika, och gav även ökad återvinning för de övriga studerade läkemedlen.Läkemedel är viktiga för hälsa och ökat välbefinnande i vårt dagliga liv. Läkemedel ger många fördelar såsom förbättrad livskvalitet, och efterfrågan kommer sannolikt att öka i framtiden på grund av en växande åldrande befolkning, kroniska livsstilssjukdomar, expanderande tillväxtmarknader samt framsteg inom den medicinska forskningen. Tyvärr innebär en ökad användning av läkemedel även en ökad belastning på miljön. Konsumtionen av mediciner bland befolkningen utgör den största spridningen av läkemedelsrester till miljön. Läkemedel som inte bryts ner helt i kroppen utsöndras, antingen som metaboliter eller i oförändrad form, via urin och avföring och hamnar i våra reningsverk. I reningsverken kan läkemedelsresterna antingen brytas ner, fastläggas i slammet eller hamna i sjöar, vattendrag och i kustvatten via det renade utgående avloppsvattnet. Utvärderingen av reningseffektiviteten av olika reningstekniker baseras vanligtvis på analyser av koncentration av läkemedelsrester. Det finns dock svårigheter med analysmetoderna då läkemedel utgör en heterogen grupp av ämnen, med stor variation i fysikaliska och kemiska egenskaper. Variationen kräver användandet av generella metoder för provberedning och analys. Påverkan från komplexa matriser, så som avloppsvatten, riskerar att försämra återvinningen av läkemedel vid provupparbetningen samt påverka signalen vid analys på instrument. Till exempel kan den höga halten av andra föreningar i inkommande avloppsvattnet störa analysen så att vissa läkemedel observeras vid lägre koncentrationer i det orenade vattnet än i det mer rena utgående avloppsvattnet. En annan orsak till att halter av läkemedel uppmäts som lägre i inkommande än utgående avloppsvatten kan vara att vissa läkemedel som metaboliseras i människokroppen återfår sin ursprungliga struktur i reningsverksprocessen och därmed uppmäts i större utsträckning i utgående avloppsvatten. Matriseffekter försämrar även detektionsgränserna av östrogena hormoner så att det med dagens analysmetoder är svårt att bestämma deras förekomst i avloppsvatten. Vissa antibiotika interagerar med fria joner från matrisen och bildar kelatkomplex, vilket ger försämrad återvinning och detektion. Då behovet är stort att kunna bedöma reningseffektivitet i avloppsreningsverk och koncentration av ämnen i avloppsvatten som kan påverka miljön har fokus för studien varit att utveckla och utvärdera förbättrade metoder för kvantitativ bestämning av läkemedelsrester i avloppsvatten. Användandet av en generell metod för provberedning och analys av läkemedel i komplexa matriser, så som avloppsvatten, gör det svårt att skilja läkedelssubstanserna från övrigt organiskt material i matrisen. Generella analysmetoder kan dock användas för att få en översiktlig bild av förekommande ämnen och halter i avloppsvatten samt för jämförelser av reningseffektivitet mellan olika reningstekniker eller olika reningsverk. I arbeten där utvärdering av reningseffektiviteten i ett avloppsreningsverk av enskilda ämnen eller halten av enskilda ämnen i utgående avloppsvatten är avgörande, kan t.ex. märkta internstandarder för respektive ämne eller metoder anpassade till enskilda ämnens kemiska fysikaliska egenskaper användas vid analys för att minimera matriseffekter. Resultaten visade att jon-suppression, dvs. nedtryckning av signalen vid analys på grund av konkurrens med koeluerande organiskt material i matrisen, var den viktigaste orsaken till den observerade ökningen i koncentration av läkemedelsrester från inkommande till utgående avloppsvatten. Resultaten visar en genomsnittlig jon-suppression på 56 % för de studerade läkemedlen i inkommande och 33 % i utgående avloppsvatten. Förluster i återvinning orsakat av konkurrens med annat organiskt material i matrisen vid provberedning alternativt omvandling av metaboliter av läkemedelsrester i avloppsvatten var av underordnad betydelse för flertalet ämnen. Risperidon och Fluoxetine visade stor påverkan av behandling avseende omvandlingsprodukter inklusive metaboliter. Utvecklingen av känsligare metod för kvantifiering av östrogena hormoner i utgående avloppsvatten resulterade i haltbestämningar under ng/L, med en kvantifieringsgräns (LOQ; S/N=10) för17-β-östradiol på 0,6 ng/L, östrone på 0,4 ng/L och 17-α-etinylöstradiol på 0,4 ng/L. Studien visade även att en tillsats av EDTA-Na2 till vattenprov innan upparbetning ökade återvinningen av merparten av de studerade antibiotika, och gav även ökad återvinning för de övriga studerade läkemedlen.Läkemedel är viktiga för hälsa och ökat välbefinnande i vårt dagliga liv. Läkemedel ger många fördelar så som förbättrad livskvalitet, och efterfrågan kommer sannolikt att öka i framtiden på grund av en växande åldrande befolkning, kroniska livsstilssjukdomar, expanderande tillväxtmarknader samt framsteg inom den medicinska forskningen. Tyvärr innebär en ökad användning av läkemedel även en ökad belastning på miljön. Denna studie är en delaktivitet i projektet ”Systemförslag för rening av läkemedelsrester och andra prioriterade svårnedbrytbara ämnen”